Monocenter, double blinded, exploratory, randomized, study investigating the influence of Pasireotide on the hormonal activity of Pheochromocytoma – proof of concept study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006824-20-DE

Enrollment

Registered

2007-07-23

Start date

2007-11-08

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pheochromocytoma MedDRA version: 9.1 Level: LLT Classification code 10034876 Term: Pheochromocytoma

Interventions

Product Code: SOM230 Pharmaceutical Form: Injection* INN or Proposed INN: Pasireotide Current Sponsor code: SOM230 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male and female patients. • Age: 18-80 years • Patients with malignant/ non-malignant Pheochromocytoma and/ or Paraganglioma as shown by: - increased plasma values of metanephrines and - confirmation by MRT/ CT not older than 3 months • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Clinically significant renal or hepatic abnormalities. • Evidence of drug/alcohol abuse. • The patient has received any unlicensed drug within 30 days prior to screening. • Known hypersensitivity to somatostatin analogs • Karnovsky-Index <60 • Pregnancy or breast-feeding • Known immunosuppression • Other malignant diseases, except Basalioma or in-situ Cervix carcinoma

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary study objective is to evaluate the rate of patients responding to a dose of 600 and 900 µg Pasireotide, given in a randomized order within two consecutive days, that is within 48 h. Response is defined as a minimal 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in urine.;Secondary Objective: • Percentage of patients, who show an at least 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in serum samples within 10 hours after the administrations of 600 or 900 µg Pasireotide. • Mean decrease of catecholamines, metanephrines and Chromogranin A in plasma and urine • Percentage of patients, who show a blood pressure drop of at least 10% over the10 h period • Dose-dependancy of any effect • Safety and tolerance of the Pasireotide administration • PK-/PD-analysis • Correlation of clinical response and receptor status, as determined by quantitative reverse real time PCR and, whenever material is available;Primary end point(s): Percentage of patients, who show an at least 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in 12 h urinary samples after the administrations of 600 or 900 µg Pasireotide.	—

Measure

Time frame

Main Objective: The primary study objective is to evaluate the rate of patients responding to a dose of 600 and 900 µg Pasireotide, given in a randomized order within two consecutive days, that is within 48 h. Response is defined as a minimal 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in urine.;Secondary Objective: • Percentage of patients, who show an at least 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in serum samples within 10 hours after the administrations of 600 or 900 µg Pasireotide. • Mean decrease of catecholamines, metanephrines and Chromogranin A in plasma and urine • Percentage of patients, who show a blood pressure drop of at least 10% over the10 h period • Dose-dependancy of any effect • Safety and tolerance of the Pasireotide administration • PK-/PD-analysis • Correlation of clinical response and receptor status, as determined by quantitative reverse real time PCR and, whenever material is available;Primary end point(s): Percentage of patients, who show an at least 25% decrease of the primarily elevated catecholamine and/ or metanephrine values in 12 h urinary samples after the administrations of 600 or 900 µg Pasireotide.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026